Biopharmaceutical company Affymax, Inc. and Takeda Pharmaceutical Company Limited (Takeda) have decided to voluntarily recall all lots of Omontys (peginesatide) injection to the user level as a result of new post-marketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies have been working actively with the US Food and Drug Administration (FDA) which has indicated its agreement with this decision.
The companies have also issued a letter to health care professionals indicating that no new or existing patients should receive Omontys.
To date, fatal reactions have been reported in approximately 0.02 per cent of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received Omontys in the post-marketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2 per cent with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.
The companies are actively investigating these cases. In the meantime, dialysis organizations are instructed to discontinue use.
Omontys (peginesatide) injection is indicated for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and is packaged in 10 mg and 20 mg multi-dose vials.
The product can be identified by its product labelling featuring the name Omontys. Omontys was distributed Nationwide, including Puerto Rico and Guam, to dialysis centres via specialty distributors.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting programme either online, by regular mail or by fax. This recall is being conducted with the knowledge of the US Food and Drug Administration.
Omontys is not indicated and is not recommended for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anaemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anaemia. Omontys has not been shown to improve symptoms, physical functioning, or health-related quality of life.
Affymax, Inc. is a biopharmaceutical company and its mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses.
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.